MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-08-14 for ULTRA-DRIVE III HANDPIECE N/A 423936 manufactured by Biomet Orthopedics.
[23002602]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. The device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-03640 / 03641).
Patient Sequence No: 1, Text Type: N, H10
[23002603]
It was reported that patient underwent a hip arthroplasty over 7 years ago. Subsequently, patient was revised on (b)(6) 2015 due to unknown reasons. During the procedure, the disk drill fractured off the ultra drive hand piece and the hand piece showed a failure message. The surgeon opened the femur in half to remove the fractured disk drill resulting in over a 90 minute delay in the procedure. Cable implants were used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[26562309]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
Patient Sequence No: 1, Text Type: N, H10
[26909737]
This follow-up report is being filed to relay corrected information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2015-03641 |
| MDR Report Key | 5004070 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-08-14 |
| Date of Report | 2015-09-01 |
| Date of Event | 2015-07-23 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA-DRIVE III HANDPIECE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2015-08-14 |
| Returned To Mfg | 2015-09-01 |
| Model Number | N/A |
| Catalog Number | 423936 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-08-14 |